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CompletedNCT04270994Updated Feb 17, 2020

Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

A Phase 2/3 interventional study of Misoprostol in Endometrial Polyps in Infertile Patients, sponsored by Henry Aristoteles Mate-Sánez. Completed. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Henry Aristoteles Mate-Sánez · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Sep 2016, registered Feb 2020).
Phase
Phase 2/3
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol

Read the detailed description

The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered "gold standard" is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.

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Conditions studied

  • Endometrial Polyps in Infertile Patients
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In context

Uterine Neoplasms

255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.

This study's enrollment of 54 is above the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.

Browse Uterine Neoplasms studies →

Lead sponsor

This is the only study on the registry with Henry Aristoteles Mate-Sánez as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age

Exclusion criteria

Exclusion Criteria:

  • Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Misoprostol

    Drug: Misoprostol

Interventions

  • DrugMisoprostol
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What researchers measure

Primary outcomes

  1. Expulsion rate of endometrial polyps

    Time frame: 7 days after misoprostol has been applied

Secondary outcomes

  1. Pregnancy rate after expulsion

    Time frame: 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)

  2. The pregnancy rate after expulsion in patients with primary sterility

    Time frame: 14-21 days after positive β-hCG

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04270994
Lead sponsor
Henry Aristoteles Mate-Sánez
Responsible party
Henry Aristoteles Mate-Sánez (Principal Investigator, Mateo-Sánez, Henry A.) — Sponsor-investigator
First posted
Feb 17, 2020
Start date
Sep 2016
Primary completion
Aug 2019
Completion
Nov 2019
Last update
Feb 17, 2020

Study contacts

HENRY A MATEO-SÁNEZ, MD
study director · Henry Aristoteles Mate-Sánez

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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